Limb Injury
Conditions
Keywords
Fentanyl, Ketamin, Limb injury, Pain, Children
Brief summary
The purpose of this study is to determine if IN fentanyl (1.5 µg/kg) or IN ketamine (1 mg/kg) is more effective at 30 minutes than oral morphine (0.5 mg/kg) in reduction of moderate and severe pain associated with limb injuries in patients 2-17 years of age presenting to the ED.
Detailed description
In children with moderate to severe pain due to musculoskeletal injuries, the first-line analgesic therapy in pediatric emergency departments (ED) is oral or intravenous morphine. Due to the delay or discomfort associated with establishing IV access, oral forms are preferred in French ED. Unfortunately, oral morphine alone or with ibuprofen or paracetamol, none regimen is optimal for relieving pain in children with traumatic limb injuries. However, the use of intranasal course is a safe route that can provide rapid and almost immediate analgesia. Intranasal administration is easy, non-invasive and usually well tolerated by children. In the last years, drugs with analgesic and sedative properties is increasing, particularly on fentanyl, ketamine, which can be also administered by the IN route. There are currently no studies, neither published nor ongoing, which compare IN fentanyl or IN ketamine to a standard oral morphine for children with acute moderate to severe pain with limb injuries presenting to the ED. The main hypothesis is that the efficacy of the analgesia 30 minutes after the administration will be higher with IN Fentanyl or with IN Ketamine, when compared to oral morphine.
Interventions
DRUGMorphine
oral morphine (0.5 mg / kg)
DRUGIN fentanyl
IN fentanyl (1.5 µg/kg)
DRUGIN ketamine
IN ketamine (1 mg/kg)
DRUGNaCl 0,9 %
Injectable solution used as Placebo of Oral morphine or IN fentanyl/ ketamine.
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Child aged 2 years to 17 years and 11 months * With 10 kg ≤ Weight ≤ 100 kg * Presenting to ED with a traumatic pain and suspected fracture(s) based on an acute deformity AND experiencing pain and/or functional impotence in the injured limb(s) * Within the first 12 hours after the injury * VAS pain score at ED arrival ≥ 60/100 (if child ≥ 7 years) or Evendol pain score at ED arrival ≥ 7/15 (if child \< 7 years) * Affiliated to health insurance * At least one signed parental informed consent
Exclusion criteria
* Received narcotic pain medication prior to arrival * Contraindication to morphine, mentioned in SmPC * Hypersensitivity to ketamine or fentanyl or to excipients (sodium chloride, sodium hydroxide), or to other opioids. * Contraindication to fentanyl or ketamine, mentioned in SmPC * GCS \<15 * Evidence of significant femur, head, chest, abdominal, or spine injury * Open fracture * Nasal trauma or complete nasal obstruction * Active epistaxis * Nasal or sinus surgery within 6 months before inclusion * History of high blood pressure, known coronary artery disease, congestive heart failure, acute glaucoma, increased intracranial pressure, major psychiatric disorder, hepatocellular insufficiency * Active or history of psychiatric disorder * Known pregnancy or suspicion of being pregnant * Breastfeeding * Non-French speaking parent and / or child. * Participation to another interventional clinical research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain (M30) | 30 minutes | Success: children \<7 years with a pain score assessed by Evendol \< 5 years, 30 minutes after drugs administration, without rescue analgesia. Scale: 0-15 (no pain - painful) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain (M15) | 15 minutes | Success: children \<7 years with a pain score assessed by Evendol \< 5, 15 minutes after drugs administration, without rescue analgesia |
| Degree of pain (M60) | 60 minutes | Success: children \<7 years with a pain score assessed by Evendol \< 5, 60 minutes after drugs administration, without rescue analgesia |
| Degree of pain (M90) | 90 minutes | Success: children \<7 years with a pain score assessed by Evendol \< 5, 90 minutes after drugs administration, without rescue analgesia |
| Degree of pain (M120) | 120 minutes | Success: children \<7 years with a pain score assessed by Evendol \< 5, 120 minutes after drugs administration, without rescue analgesia |
| Reduction in pain (M15) | 15 minutes | Reduction in pain from baseline assessed by Evendol for children \<7 years |
| Reduction in pain (M30) | 30 minutes | Reduction in pain from baseline assessed by Evendol for children \<7 years |
| Reduction in pain (M60) | 60 minutes | Reduction in pain from baseline assessed by Evendol for children \<7 years |
| Reduction in pain (M90) | 90 minutes | Reduction in pain from baseline (assessed by VAS for children ≥ 7 years) |
| Reduction in pain (M120) | 120 minutes | Reduction in pain from baseline assessed by VAS for children ≥ 7 years |
| Degree of pain (M30) for comparison ketamine vs fentanyl | 30 minutes | Success pain evaluation, as defined in primary outcome (for the comparison between ketamine and fentanyl) assessed by Evendol for children \<7 years |
| Level of sedation (M5) | 5 minutes | Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable) |
| Level of sedation (M10) | 10 minutes | Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable) |
| Level of sedation (M15) | 15 minutes | Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable) |
| Level of sedation (M30) | 30 minutes | Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable) |
| Level of sedation (M60) | 60 minutes | Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable) |
| Level of sedation (M90) | 90 minutes | Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable) |
| Level of sedation (M120) | 120 minutes | Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable) |
| Number of participants with Adverse events | From study treatment intake until ED discharge, up to 1 day | Adverse events potentially associated with IN ketamine, IN fentanyl and/or oral morphine: drowsiness, dizziness, pruritus, nausea, vomiting, dysphoria, nasal burning and irritation, unpleasant taste, vision changes, throat irritation, headache, vital sign changes (heart rate, respiratory rate, oxygen saturation, blood pressure). |
| Score of satisfaction | At ED discharge, up to 1 day | General satisfaction of parents and patient ≥ 7 years old on a scale of 0-100 with corresponding faces (0 = no satisfaction at all, 100 = very satisfied) |
Countries
France
Contacts
CONTACTHélène CHAPPUY, MD, PhD
CONTACTNelly BRIAND, PhD
PRINCIPAL_INVESTIGATORHélène CHAPPUY, MD, PhD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed